Labcompliance On-line Audio Seminar
On-line Audio Seminar 103
This seminar has been recorded on a CD. All reference material as
listed below and more is available on a special seminar website. The
website is regularly updated with most recent information. In case
there are questions related to the topic, they can be submitted
through a web form and will be answered by the speaker. For ordering
info click here
Part 11 Case Studies
The Ultimate Answers and Tools You Need to Define
and Document Your Part 11 Scope and Controls
FDA has made decisions to narrow the scope of part 11. Inspections are coming
and inspectors want to know if and how we did implement the narrow scope. Our
managers want to have a justification for our part 11 investments. The problem
is that many times we really don't know what to do. Good advice is rare and most
of the time the answers are: "it depends", "look at the predicate rules", or
"make a risk assessment".
- What is in and what is out of the narrow scope?
- How to assess the risk of my system?
- Now I know my system should comply with part 11 but which
controls should I implement?
- What are the real criteria for the various controls like
e-audit trail, reprocessing of data, archiving on paper or as
- How to justify document my decision?
- Where can I get examples?
How does the audio seminar help:
Step by step instructions will be presented by Dr. Ludwig Huber
in a new interactive audio seminar. During the seminar, the speaker
will use 10+ examples to demonstrate how to make rational decisions
on scope and controls. After the seminar, an extensive list of
reference material like diagrams, checklists, SOPs and templates
will help immediate and cost effective implementation.
During the interactive presentation you learn about:
- Step by step instruction how to justify and document
- Going through SOPs and templates
- Practice on 10+ examples from laboratories, offices (Word,Excel),
manufacturing, clinical studies
- Learn how to justify document for your managers
- Learn how to justify and document for the FDA
And for easy and instant implementation:
download 10+ documents from special seminar website
- Define and document scope and controls for part 11
- Risk analysis for part 11
- Training for GxP and Part 11
- 10 Examples in Powerpoint to illustrate business processes
- MS Word template to document your decision with examples.
- Part 11 Gap analysis
- Biopharm publication: New Scope of Part 11
- FDA 483 form inspectional observations, establishment
inspection reports and several warning letters with deviations
related to part 11
- And more....
Who should attend?
- Part 11 project managers
- Members of Part 11 task forces
- QA managers and personnel
- Production and lab managers
- Regulatory affairs
- Validation specialists
- Training department
- Documentation department
How to order
Pick one of the options in the table that fits
Replaced by the more recent seminar
Implementing FDA's 'New' 21 CFR
Strategies and 10 Case Studies from
Manufacturing, Offices and Laboratories
About audio seminars
Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- Ask questions through email and web form
About Dr. Ludwig Huber
Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
||Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.
Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,